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neffy ® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP...
CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated ...
Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA Guidance Submission...